How does this medication work? What will it do for me?

Amphetamine belongs to the family of medications known as stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD). It helps to increase attention and decrease hyperactivity and impulsiveness in children over 6 years of age, adolescents, and adults who have been diagnosed with ADHD.

Other measures (e.g., psychological, educational, and social therapies) are used along with mixed salts amphetamine as part of an overall treatment program for ADHD. An improvement in ADHD symptoms can be seen within one week of starting the medication.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual starting dose is 10 mg taken once daily in the morning. The dose is usually started low and increased gradually. The dose of this medication needs to be individualized according to the needs of the person taking the medication. Doses above 30 mg daily are not recommended.

This medication may be taken with or without food. Swallow this medication whole with water or other liquids. Do not crush or split the capsules. The capsule contains small pellets of medication specially designed to release their contents slowly inside the body. The capsule may be opened and the contents sprinkled over applesauce. The applesauce should be eaten immediately after sprinkling and not stored for later. Avoid chewing the applesauce – chewing could damage the pellets from the capsule. Eat all of the sprinkled applesauce to make sure you get the full dose.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Taking a dose in the afternoon may cause difficulty sleeping, and should therefore be avoided. Do not take a double dose to make up for a missed one.If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

are allergic to mixed salts amphetamine extended release or any ingredients of the medication

are allergic or sensitive to a group of medications known as sympathomimetics (e.g., pseudoephedrine, epinephrine, norepinephrine)

are agitated

are taking a monoamine oxidase (MAO) inhibitor medication (e.g., phenelzine, tranylcypromine) or have taken one in the last 14 days

have a history of drug abuse

have advanced hardening of the arteries

have an overactive thyroid gland

have glaucoma (increased pressure in the eye)

have heart disease

have moderate-to-severe high blood pressure

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

diarrhea

dizziness

dry mouth

headache

appetite changes (increased or decreased)

mood changes

nausea

stomach ache

trouble falling asleep

vomiting

weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

anxiety or nervousness

behavior changes (e.g., aggressiveness, agitation, anger, hostility)

blurred vision or other vision changes

fast heartbeat or heart palpitations

hallucinations (hearing, seeing, or feeling things that are not actually there)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

[March 30, 2015]

Health Canada has issued new restrictions concerning the use of drugs used in the management of Attention Deficit Hyperactivity Disorder (ADHD). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Behaviour or mood changes: There have been reports of agitation, hallucinations, symptoms of depression, and thoughts of self-harm in people taking this medication. If you experience these types of symptoms while taking mixed salts amphetamine, contact your doctor immediately.

Bipolar disorder: This medication may trigger a mixed or manic episode in people with bipolar disorder. If you have a history of bipolar disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Tell your doctor of any new or worsening mental problems while taking this medication.

Blood pressure: This medication can increase blood pressure and heart rate. Blood pressure should be monitored at appropriate intervals by your doctor. If you have high blood pressure, heart problems, or you have recently had a heart attack, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drug dependence: Due to the possibility for some individuals to develop a dependence on amphetamines, people with a history of drug or alcohol dependence should be closely monitored by their doctor while using this medication.

Epilepsy: There is some evidence that mixed salts amphetamine may increase the risk of seizures, particularly for people who have had seizures in the past. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Exercise: Strenuous exercise may increase the risk of heart problems for people taking mixed salts amphetamine. People participating in strenuous exercise or activities should consult their doctor before taking mixed salts amphetamine extended release.

Heart problems: This medication can increase the risk of sudden death for people with heart problems. If you have heart problems, including an irregular heartbeat, or a family history of sudden death related to heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication should generally not be used by people with known structural heart abnormalities, such as abnormal size, missing or poorly functioning heart valves, or problems with blood vessels connected to the heart.

Mental Health: Stimulant medications such as mixed salts amphetamine extended release appear to make behavior and thought disturbances worse for people who have psychotic conditions. They may also cause symptoms of psychosis and mania to develop in people who have not had these symptoms before. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

If you have a history of psychosis or other mental illness such as depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Suppression of growth: It is not known if mixed salts amphetamine extended release causes growth suppression in children (i.e., less growth in height or weight than usual). However, this has been reported for children who use stimulants such as mixed salts amphetamine over long periods of time. Children who need long-term treatment should be carefully monitored for growth. Their doctor may also recommend a "drug holiday," where the medication is not given on weekends or during school holidays.

Tics: This medication may cause tics or worsening of motor or verbal tics. If you have Tourette's syndrome or develop tics while on this medication, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vision problems: Difficulties with vision such as blurring of vision have been reported with stimulant use. If this problem persists, talk to your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking mixed salts amphetamine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for and should not be used by children under 6 years of age.

What other drugs could interact with this medication?

There may be an interaction between mixed salts amphetamine extended release and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,

change one of the medications to another,

change how you are taking one or both of the medications, or

leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than the ones listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.